Global Import Regulations for
Revised September 2003
Table of Contents
Executive Summary vi
Market Listings 1
Costa Rica 34
Czech Republic 35
Dominican Republic 37
El Salvador 38
European Union 42
Hong Kong 54
Korea, South 64
New Zealand 88
Saudi Arabia 111
Serbia and Montenegro 111
South Africa 114
Sri Lanka 120
Trinidad & Tobago 125
United Arab Emirates 131
United Kingdom 132
Conclusions and Next Steps 142
Proposed Voluntary Self-Regulation of the
Pre-Owned Medical Device Industry 146
This is the fifth edition of a report first issued in May 1999. This report seeks to collect and compile information on the regulations relating to the importation of pre-owned (used and refurbished) capital medical equipment in countries around the world. It also includes some information on market demand for such equipment.
Although this report is intended to serve as a general reference, it is not a definitive study and data is not available or is incomplete for many countries. This report is formally updated annually, but revisions to the country entries are made throughout the year if new material becomes available.
This report does not attempt to address the issue of re-use of single-use devices (SUDs). Such re-use remains a controversial practice and poses different safety issues than pre-owned capital equipment, which is designed for use with multiple patients over many years. Moreover, single-use devices are typically reprocessed by or for the original purchaser and thus generally do not enter into international trade.
The second of these questions was asked for the first time in 2003 in order to clarify the ability of refurbishers—especially those not affiliated with the original equipment manufacturer (OEM)—to readily ship refurbished devices internationally.
The responses provided by the trade specialists vary from full-length reports—typically International Market Insight (IMI) or Industry Sector Analysis (ISA) reports—to short replies submitted by cable or e-mail. In many cases, the specialists simply confirm the existing entry. Entries submitted in report format are given the title and date of the report. Other entries are simply identified by whether they were submitted to OMMI by cable or e-mail and the date it was submitted. If the trade specialist confirms information submitted in previous years, both the original date of submission and the date of the confirmation are provided.
Thirty-four CS posts responded to the cable in 2003, somewhat fewer than in past years, perhaps reflecting the generally lack of change in import regulations for pre-owned medical devices. The 34 responding posts either prepared new IMI reports on pre-owned-medical equipment or sent a cable or e-mail to OMMI addressing the above questions.
The report also includes a small number of reports on the medical-device sector prepared by the CS trade specialists independently of OMMI’s request for information on the used-equipment sector, as well as some cables that many CS posts submitted in 1998 in response to a request from the Department of Commerce soliciting information on import regulation for used and refurbished equipment generally. Entries based on responses to this request carry a source indicating that they were submitted by the CS post via cable and bear a date in 1998.
Although an effort has been made to preserve the text of the original sources as much as possible, text has been reformatted and abridged in order to present a standardized and concise format. In some cases, the original sources have been summarized or edited.
In addition, many of the cables that were in response to the 1998 request for information about import regulations for used/refurbished equipment do not explicitly deal with medical equipment. The reporting officer, for example, may have looked only at general import regulations and thus not considered the possibility of more restrictive health regulations that affect the importation of used medical devices.
Finally, medical regulations are constantly changing. What may have been accurate when the market research was prepared may not be the case today. In addition, custom or health officials may interpret regulations that do not seem to present a problem in such a way as to result in market restrictions.
Users of this report are encouraged to inform OMMI of any information found to be out of date or inaccurate. Contact:
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